Clinitec Patient Randomisation

The randomisation of patients to a treatment
group is a critical component of every Clinical Trial. Clinitec's Interactive Voice Response System (IVRS) and Interactive
Web Response System (IWRS) provide convenient, real-time,
secure, confidential access to a centralised study database
to help manage this process - with a focus on Phase II and III trials.

The IVRS, combined with the ubiquitous phone
and fax services, makes study deployment fast and easy. The
IWRS allows study administrators and investigators to securely
interact with the study database using a standard web browser
and email services. Both services can be accessed from any
location worldwide and, for flexibility, you can choose to
implement both of these technologies concurrently if desired.

The IVRS and IWRS services, and the initial
study preparations and documentation, fit into the familiar
manual processes of organisations running clinical trials.

Randomisation Protocol

In developing randomisation protocol for a trial, the first
step is to identify a small number of patient characteristics
that need to be balanced between treatment groups, referred
to as "stratification variables." A number of algorithms have
been developed to reduce the chance of imbalance between treatment
groups. These work by making it more likely that a patient
with a particular characteristic is allocated to the group
in which this characteristic is under-represented at the time
of randomisation.

The Trial Sponsor is responsible for defining
the randomisation methodology or the creation of the Randomisation
tables and these are provided to Clinitec at the start of
the trial. They are then loaded into the Clinitec system database
for access via either IVRS or Web.

Optional Functions

Forced Randomisation - if inventory levels dictate that this is necessary at a particular site

Emergency Unblinding - in an emergency, details of the assigned
Treatment Group can be obtained

Drug Dispensing - at the time of Randomisation and also on subsequent scheduled visits

Trial Management

Clinitec initially works with its clients to develop a Systems
Requirements Specification for each study. Then we use pre-developed
templates to speed the development of all associated documents
(Worksheets, Faxes, Reports, Access Envelopes and User Manuals).

A complete IVRS test environment is then established for final validation.

Each Investigator and Administrator is given a secure envelope with initial access details and a user manual.
On site, the Monitors and Investigators complete the Account Setup Worksheet and call the IVRS (or login to IWRS) to setup their individual accounts, and they may choose their own PIN.

Subsequently, to randomise a patient to a study, Investigators call the IVRS (or login to IWRS) and follow the prompts to input patient data. A confirmation fax or email is then sent to the site.